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Clinicopathological Features of NSCLC Patients Associated With the Chromosome 2p (EML4-ALK) (ALK)

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ClinicalTrials.gov Identifier: NCT01662635
Recruitment Status : Completed
First Posted : August 10, 2012
Results First Posted : November 21, 2014
Last Update Posted : January 9, 2019
Information provided by (Responsible Party):
Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico

Brief Summary:
Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.

Condition or disease
Non Small-cell Lung Cancer

Detailed Description:

Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged.

FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with >15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning.

The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice, FISH. Further, we report on the demographics, and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population.

Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17

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Study Type : Observational
Actual Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : February 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer


We reviewed 230 consecutive cases of NSCLC that were retrieved from oncologic molecular laboratory and diagnostic pathology unit at the Instituto Nacional de Cancerologia, Mexico city, between 2011 and 2014. Samples were sent to the unit of pathological anatomy, a Pathologist confirmed the histologic diagnosis. The only inclusion criterion was the availability of tissue for biomarker studies. Clinical and pathologic details of these patients were included in a database, obtained from medical records.

For ALK fusion testing, we applied dual-color, break-apart FISH, RT-qPCR, and immunohistochemistry. Interpretation of the results was done in double-blind manner without knowing the results by other methods.

Primary Outcome Measures :
  1. FISH, IHC, RT-qPCR Comparison [ Time Frame: TWO YEARS ]
    200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.

Biospecimen Retention:   Samples With DNA

FISH studies were performed in 3-mm to 4-mm thick paraffin sections from 230 NSCLCs and 1 ALCL specimen with t(2;5) that was used as a positive control for the break-apart detection.

48 patients were analyzed for the presence of EML4-ALK gene fusion variants using the RNA from frozen tissue sections

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Mexican pupulation, with Non small-cell lung cancer.

Inclusion Criteria:

  • The only inclusion criterion was the availability of tissue for biomarker studies.

Exclusion Criteria:

  • Disease Progression

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662635

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Instituto Nacional de Cancerologia
Mexico, DF, Mexico, 14080
Sponsors and Collaborators
Instituto Nacional de Cancerologia de Mexico
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Principal Investigator: Oscar Arrieta, MD Instituto de Cancerología
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Responsible Party: Oscar Gerardo Arrieta Rodríguez MD, MD and medical oncologist, Instituto Nacional de Cancerologia de Mexico
ClinicalTrials.gov Identifier: NCT01662635    
Other Study ID Numbers: INCAN/CC/039/11
First Posted: August 10, 2012    Key Record Dates
Results First Posted: November 21, 2014
Last Update Posted: January 9, 2019
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Oscar Gerardo Arrieta Rodríguez MD, Instituto Nacional de Cancerologia de Mexico:
Non-small cell lung cancer.
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms